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March 12, 2026Clinical Pharmacology in Drug Development2 citationsOpen Access

Phase 1 Study of CIN‐102 Effects on Cardiac Repolarization in Healthy Volunteers

Results of a Phase 1 Study Assessing the Effect of CIN‐102, a Novel Formulation of the Dopamine Receptor Antagonist Domperidone Designed to Treat Gastroparesis, on Cardiac Repolarization in Healthy Volunteers

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Why the study?

Does single-dose deuterated domperidone (CIN-102) prolong the QT interval compared to placebo in healthy volunteers?

Population

62 healthy volunteers

Comparison

Single doses of 30-mg and 100-mg deuterated… vs Placebo and moxifloxacin (positive control)

Design

RCT, 4-period randomized crossover

Key result

CIN-102 did not exert a clinically meaningful effect on QTc interval, with no ΔΔQTcF exceeding 10 ms at therapeutic and supratherapeutic doses.

Authors

MBMary BondBMBrian MurphyBDBrendan Doran

Discussion

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Overview

Supports QT-safe CIN-102 use in practice; confirms deuteration mitigates domperidone’s QT effects.

Key Points

  • The aim is to assess the effects of the novel formulation CIN-102 on cardiac repolarization in healthy individuals.
  • Conducted a phase 1, 4-period randomized crossover study in 62 healthy volunteers.
  • Administered single doses of 30 mg and 100 mg CIN-102, along with placebo and moxifloxacin.
  • Collected continuous 12-lead electrocardiograms (ECGs) and blood samples for analysis.
  • Measured placebo-corrected changes in QTc corrected by Fridericia's formula (ΔΔQTcF).
  • CIN-102 did not exceed a 10 ms change in ΔΔQTcF across all time points and doses.
  • No significant effects on heart rate or cardiac conduction were observed.
  • No deaths or serious adverse events reported.

Structured PICO

Does single-dose deuterated domperidone (CIN-102) prolong the QT interval compared to placebo in healthy volunteers?

P
Population
62 healthy volunteers
I
Intervention
Single doses of 30-mg (therapeutic exposure) and 100-mg (supratherapeutic exposure) deuterated domperidone (CIN-102)
C
Comparator
Placebo and moxifloxacin (positive control)
O
Outcome
Placebo-corrected change-from-baseline QTc corrected by Fridericia's formula (ΔΔQTcF)safety

A novel deuterated formulation of domperidone (CIN-102) does not cause clinically meaningful QT prolongation at therapeutic or supratherapeutic doses in healthy volunteers.

Cite This Study

Bond et al. (2026) studied this question. CIN-102 did not exert a clinically meaningful effect on QTc interval, with no ΔΔQTcF exceeding 10 ms at therapeutic and supratherapeutic doses.

synapsesocial.com/papers/69b257bf96eeacc4fcec69echttps://doi.org/10.1002/cpdd.70039
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